Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient (tdcs)

Mass General Brigham

Status: Completed

Conditions: Healthy; Stroke

Treatments: Device: transcranial alternating current stimulation (tACS); Device: transcranial direct current stimulation (tDCS); Procedure: constraint induced movement therapy (CIMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01143649

2009p001808

Details and patient eligibility

About

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.

Full description

In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment on tACS uses a crossover design (exp 3).

For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.

Enrollment: 44 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must be between the ages of 18-90 and must not be pregnant.

Additional Entry criteria for Stroke subject enrollment:

1. First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;
2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
3. Stroke onset >6 months prior to study enrollment.

Exclusion criteria

1. Significant pre-stroke disability;

2. Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);

3. Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;

4. Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);

5. Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants

   • history of seizures
   • unexplained loss of consciousness
   • metal in the head
   • frequent or severe headaches or neck pain
   • implanted brain medical devices.

6. Contraindications to tDCS

   • metal in the head
   • implanted brain medical devices

7. Advanced liver, kidney, cardiac, or pulmonary disease;

8. A terminal medical diagnosis consistent with survival < 1 year;

9. Coexistent major neurological or psychiatric disease as to decrease number of confounders;

10. A history of significant alcohol or drug abuse in the prior 6 months;

11. Use of carbamazepine and amitriptyline;

12. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and

13. Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke;

14. History of epilepsy before stroke (or episodes of seizures within the last six months).

15. Subjects with global aphasia and deficits of comprehension

16. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 6 patient groups

active tDCS + CIMT - stroke patients

Experimental group

Description:

Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday).

Treatment:

Procedure: constraint induced movement therapy (CIMT)

Device: transcranial direct current stimulation (tDCS)

active tDCS + CIMT - Healthy

Experimental group

Description:

Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT)

Treatment:

Procedure: constraint induced movement therapy (CIMT)

Device: transcranial direct current stimulation (tDCS)

tACS - Healthy Subjects

Experimental group

Description:

The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).

Treatment:

Device: transcranial alternating current stimulation (tACS)

sham tDCS + CIMT - stroke patients

Sham Comparator group

Description:

Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday). For the sham session, tDCS is turned off after 30seconds.

Treatment:

Procedure: constraint induced movement therapy (CIMT)

Device: transcranial direct current stimulation (tDCS)

sham tDCS + CIMT - Healthy

Sham Comparator group

Description:

Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.

Treatment:

Procedure: constraint induced movement therapy (CIMT)

Device: transcranial direct current stimulation (tDCS)

sham tACS - Healthy Subjects

Sham Comparator group

Description:

The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.

Treatment:

Device: transcranial alternating current stimulation (tACS)